Impending Sense Of Regulatory Panic? EU's MDR/IVDR One Year On
It has been one year since the EU Medical Device and IVD Regulations took effect, leaving two years before the MDR fully applies and four before the IVDR fully applies. What has been achieved? And why is there a sense of panic among some in industry?
You may also be interested in...
ASEAN Medtech Update: Thai Device Law Amended; Vietnam Moots Another Delay; Indonesian Reg System Updated
This month's Asian Medtech Associations' Regulatory Networking discussions focused on amended Thai medical device regulations, more concerns over Vietnam's already-deferred, dedicated medtech legislation, and regulatory news updates from Indonesia. There was also a further take on compliance with the EU MDR, seen from an EU manufacturer's viewpoint. This Asia Networking series is hosted by Medtech Insight and sponsored by the Asia Regulatory and Quality Consultancy (ARQon), and the Asia Regulatory Professionals Association (ARPA).
Many companies are pinning hopes on being able to use the EU Medical Device Regulation's four-year extension period for products CE marked under the current directives. But with a lack of clarity from the policymakers so far, TEAM-NB has stepped in.
Whatever the hurdles to compliance with the new EU Medical Device and IVD Regulations, procrastination will cost firms dearly, says Peter Rose, of compliance consulting firm Maetrics. In an interview with Medtech Insight, he stresses the urgency of quick action and calculates the cost to companies that are late to to comply.